Item | Information |
---|---|
CAS RN | 79983-71-4 |
Chemical Name | 2-(2,4-dichlorophenyl)-1-(1H-1,2,4-triazol-1-yl)-2-hexanol; Hexaconazole |
Substance ID | R02-B-122-MHLW |
Classification year (FY) | FY2020 |
Ministry who conducted the classification | Ministry of Health, Labour and Welfare (MHLW) |
New/Revised | Revised |
Classification result in other fiscal year | FY2006 |
Download of Excel format | Excel file |
Item | Information |
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Guidance used for the classification (External link) | GHS Classification Guidance for the Japanese Government (FY2019 revised edition (Ver. 2.0)) |
UN GHS document (External link) | UN GHS document |
Definitions/Abbreviations (Excel file) | Definitions/Abbreviations |
Model Label by MHLW (External link) | MHLW Website (in Japanese Only) |
Model SDS by MHLW (External link) | MHLW Website (in Japanese Only) |
OECD/eChemPortal (External link) | eChemPortal |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
2 | Flammable gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
3 | Aerosols | Not classified (Not applicable) |
- |
- | - | Not aerosol products. It was classified as "Not classified." |
4 | Oxidizing gases | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
5 | Gases under pressure | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
6 | Flammable liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
7 | Flammable solids | Classification not possible |
- |
- | - | No data available. |
8 | Self-reactive substances and mixtures | Not classified (Not applicable) |
- |
- | - | There are no chemical groups present in the molecule associated with explosive or self-reactive properties. It was classified as "Not classified." |
9 | Pyrophoric liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
10 | Pyrophoric solids | Classification not possible |
- |
- | - | No data available. |
11 | Self-heating substances and mixtures | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid (melting point <= 140 deg C) substances are not available. |
12 | Substances and mixtures which, in contact with water, emit flammable gases | Not classified (Not applicable) |
- |
- | - | The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified." |
13 | Oxidizing liquids | Not classified (Not applicable) |
- |
- | - | Solid (GHS definition). It was classified as "Not classified." |
14 | Oxidizing solids | Not classified (Not applicable) |
- |
- | - | The substance is an organic compound containing chlorine and oxygen (but not fluorine) which are chemically bonded only to carbon or hydrogen. It was classified as "Not classified." |
15 | Organic peroxides | Not classified (Not applicable) |
- |
- | - | Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified." |
16 | Corrosive to metals | Classification not possible |
- |
- | - | Classification is not possible because test methods applicable to solid substances are not available. |
17 | Desensitized explosives | Not classified (Not applicable) |
- |
- | - | There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
1 | Acute toxicity (Oral) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1) - (4). [Evidence Data] (1) LD50 for rats: males: 2,190 mg/kg, females: 6,070 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (2) LD50 for rats: males: 2,189 mg/kg, females: 6,071 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) (3) LD50 for rats: males: 4,010 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (4) LD50 for rats: males: 4,013 mg/kg (A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) |
1 | Acute toxicity (Dermal) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LD50 for rats: > 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) |
1 | Acute toxicity (Inhalation: Gases) | Not classified |
- |
- | - | [Rationale for the Classification] Solid (GHS definition). It was classified as "Not classified." |
1 | Acute toxicity (Inhalation: Vapours) | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
1 | Acute toxicity (Inhalation: Dusts and mists) | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1). [Evidence Data] (1) LC50 for rats (nose exposure, 4 hours): > 5.9 mg/L (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)) |
2 | Skin corrosion/irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) This substance was not irritating to the skin of rabbits (JMPR (1990)). (2) In a skin irritation test with rabbits, no irritation was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). |
3 | Serious eye damage/eye irritation | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). The classification result was changed based on new data and by reviewing rationale data. [Evidence Data] (1) After application of this substance to the rabbit eye, conjunctival redness and chemosis were observed at 1 hour after application but were reversible within 72 hours (JMPR (1990)). (2) In an eye irritation test with rabbits, conjunctival redness and discharge of the score 1 at 24/48/72 hours application were observed, but redness disappeared within 7 days, and slight irritation was found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). |
4 | Respiratory sensitization | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
4 | Skin sensitization | Category 1B |
Warning |
H317 | P302+P352 P333+P313 P362+P364 P261 P272 P280 P321 P501 |
[Rationale for the Classification] It was classified in Category 1B from (1). [Evidence Data] (1) In a skin sensitization test with guinea pigs (maximization test, intradermal administration 4.5%), slight or moderate skin sensitization (positive rate 38%) was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), A pesticide abstract and evaluation report (Food and Agricultural Materials Inspection Center, 2014)). |
5 | Germ cell mutagenicity | Not classified |
- |
- | - | [Rationale for the Classification] It was classified as "Not classified" from (1), (2). [Evidence Data] (1) As for in vivo, it was reported to be negative in a dominant lethal test by oral administration to mice and a micronucleus test with bone marrow cells after intraperitoneal administration to mice (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015), JMPR (1990)). (2) As for in vitro, it was reported to be negative in a bacterial reverse mutation test, a chromosomal aberration test, a gene mutation test, and an unscheduled DNA synthesis test using cultured mammalian cells (same as the above). |
6 | Carcinogenicity | Category 2 |
Warning |
H351 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] It was classified in Category 2 from (1) - (3). An investigation was conducted by using new information sources, and the classification result was changed. [Evidence Data] (1) As for classification results by domestic and international organizations, EPA classified it in Group C (Possible Human Carcinogen) (EPA Annual Cancer Report 2019 (Access on November 2020): classified in 1999). (2) In a combined chronic toxicity/carcinogenicity test by 2-year diet administration of this substance to male and female rats, a significant increase in the incidence of Leydig cell tumors in the testis was observed in males (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a carcinogenicity test by 2-year diet administration of this substance to male and female mice, no neoplastic lesions with treatment-related increases in incidence were found (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). |
7 | Reproductive toxicity | Category 2 |
Warning |
H361 | P308+P313 P201 P202 P280 P405 P501 |
[Rationale for the Classification] Based on (1), effects observed in fetuses at a dose at which no maternal toxicity was observed were mild, and effects on fetuses at a dose at which maternal toxicity was observed were not determined to be malformations either. However, since the post-implantation loss increased, and many variations, etc. were observed, it was classified in Category 2. Based on a new information source, the classification result was changed from the previous classification. [Evidence Data] (1) In a developmental toxicity study with female rats dosed by gavage on days 6 to 15 of gestation, at a dose (25 mg/kg/day) at which no maternal toxicity was observed, the incidence of the 14th rib increased in fetuses, and at a dose (250 mg/kg/day) at which maternal toxicity (sacrifice in extremis (1 animal which showed the sign of abnormal delivery), reduced body weight gain, a decrease in food consumption, and stained fur) was observed, an increase in post-implantation loss due to late embryo deaths was observed, and in fetuses, low body weight, moderate dilatation and meandering of the unilateral ureter, partial ossification of the cervical rib and 4th and 6th sternebrae, unossified 1st cervical vertebra, partial ossification of the 7th cervical vertebral transverse processes of both sides, partial ossification of the 7th cervical vertebral transverse process of one side, and delayed ossification of the forelimbs and hindlimbs were observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). [Reference Data, etc.] (2) In a two-generation reproductive study with rats dosed by feeding, in parent animals, reduced body weight gain, a decrease in food consumption, increases in absolute and corrected liver weight, hepatocyte vacuolation, fatty changes of hepatocytes, etc. were observed in males and females of a group treated at 1,000 ppm; and in offspring, reduced body weight gain, hepatocyte vacuolation, and fatty changes of hepatocytes were observed in males and females of a group treated at the same dose. No effect on fertility was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In a developmental toxicity study with female rabbits dosed by gavage on days 6 to 19 of gestation, low fetal weight was observed at a dose (25 mg/kg/day) at which no maternal toxicity was observed; and an increase in the incidence of the 13th lib and 27 vertebrae before the sacral vertebra was observed in fetuses at a dose (100 mg/kg/day) at which maternal toxicity (low body weight, reduced body weight gain, and a decrease in food consumption) was observed. No teratogenicity was observed (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). |
8 | Specific target organ toxicity - Single exposure | Category 2 (nervous system) |
Warning |
H371 | P308+P311 P260 P264 P270 P405 P501 |
[Rationale for the Classification] There was no report on effects of an acute exposure to this substance in humans. In test animals, based on (1) to (4), it was classified in Category 2 (nervous system). A new information source was used and the classification results were changed from the previous classification. [Evidence Data] (1) In an acute oral toxicity test with rats, piloerection, dehydration, and signs of urinary incontinence were observed at or above 1,000 mg/kg (within the range for Category 2); and upward curve in the spine, and abnormal breathing were observed at or above 3,000 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) In an acute oral toxicity test with rats, hypoactivity and dehydration in males and females, and upward curve in the spine in males were observed at or above 510 mg/kg (within the range for Category 2); absence of stability, subnormal temperature, piloerection, a decrease in righting reflex, a decrease in respiration, and coma in males and females, signs of urinary incontinence in males, and urinary incontinence and its signs in females were observed at or above 1,093 mg/kg (within the range for Category 2); and urinary incontinence in males was observed at or above 3,311 mg/kg (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) In an acute dermal application test with rats, urinary incontinence, upward curve in the spine, smudge around the nose and mouth, red tears, and ventral depression were observed at 2,000 mg/kg (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (4) In a 4-hour inhalation exposure test with rats, abnormal breathing, lacrimation, walking with toes turned out, signs of urinary incontinence, and absence of grooming were observed at 5.9 mg/L (exceeding Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). |
9 | Specific target organ toxicity - Repeated exposure | Category 1 (liver), Category 2 (adrenal gland) |
Danger Warning |
H372 H373 |
P260 P264 P270 P314 P501 |
[Rationale for the Classification] Based on (1) to (4), it was classified in Category 1 (liver) and Category 2 (adrenal gland). As a result of a review based on the new information, the classification results were changed from the previous classification. [Evidence Data] (1) As a result of a 90-day test with rats dosed by feeding, a decrease in triglyceride, an increase in liver weight, centrilobular hepatocyte hypertrophy and fatty changes, and vacuolation of the adrenal cortex were observed in males at or above 500 ppm (males/females: 41.0/44.8 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (2) As a result of a 90-day oral toxicity test with dogs, an increase in ALP and fatty changes of hepatocytes in males and females, an increase in ALT, etc. in males, and decreases in albumin and triglyceride in females were observed at or above 25 mg/kg/day (within the range for Category 2); and vomiting, abnormal gait or behavior, etc. in males and females, and decreases in albumin and triglyceride in males were observed at 75/50 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). (3) As a result of a one-year chronic toxicity study with dogs dosed by gavage, an increase in ALP and an increase in liver weight in males and females, fatty changes of hepatocytes (focal, periportal) in males, and an increase in platelet count in females were observed at or above 10 mg/kg/day (within the range for Category 1); and an increase in ALT, etc., an increase in kidney weight, fatty changes of hepatocytes (diffuse), and hemosiderin deposit of Kupffer cells in males and females, and an increase in platelet count, and hepatic fibrosis around the central vein in females were observed at 50 mg/kg/day (within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)) (4) As a result of a two-year combined chronic toxicity/carcinogenicity study with rats dosed by feeding, vacuolation of hepatocytes and diffuse/sporadic fatty changes of hepatocytes in males were observed at or above 100 ppm (males/females: 4.58/6.09 mg/kg/day, within the range for Category 1); and an increase in liver weight, hepatocyte hypertrophy, and centrilobular fatty changes of hepatocytes in males and females, increases in ALT and AST, a decrease in triglyceride, hepatic spongy degeneration, and fatty vacuolation of the adrenal cortex in males, and an increase in cholesterol in females were observed at 1,000 ppm (males/females: 47.0/60.5 mg/kg/day, within the range for Category 2) (Risk Assessment Report (Pesticides) (Food Safety Commission of Japan, 2015)). |
10 | Aspiration hazard | Classification not possible |
- |
- | - | [Rationale for the Classification] Classification not possible due to lack of data. |
Hazard class | Classification | Pictogram Signal word |
Hazard statement (code) |
Precautionary statement (code) |
Rationale for the classification | |
---|---|---|---|---|---|---|
11 | Hazardous to the aquatic environment Short term (Acute) | - |
- |
- | - | - |
11 | Hazardous to the aquatic environment Long term (Chronic) | - |
- |
- | - | - |
12 | Hazardous to the ozone layer | - |
- |
- | - | - |
|